For the second time in a year, people who received tendons, cartilage and other parts from donated cadavers are being urged to get tested for hepatitis and the AIDS virus because of scandals involving tissue suppliers.
How much risk do they face?
Answering that is tough right now because federal officials will not say how many people around the country had already received tissue by the time recalls were announced. Or which types of tissue were involved and how it was treated.
Patients may not even be aware they received cadaver tissue, which is used for everything from back surgery to dental implants. Not all doctors even tell their patients they’ll be getting donated human tissue. Doctors themselves often don’t know where the tissue came from — especially since it often is procured, tested and treated by different companies.
However, two steps can give patients a pretty good idea of their potential risks, experts say:
- Pressing your doctor for details on the companies that supplied your tissue and whether any are involved in the recalls.
- Getting the infectious disease tests that health officials recommend — HIV, hepatitis B and C, and syphilis.
“If they’re six months out (from the transplant) and they test negative, they don’t have to worry,” said Dr. L. Clifford McDonald, an infectious disease specialist at the federal Centers for Disease Control and Prevention.
Chances are good that an infection would have taken hold by then, or at least shown up in blood tests, he said.
More than 1.3 million procedures each year — ranging from knee repairs to cornea transplants to spine surgeries — use tissue from donated cadavers. Most are supplied by reputable companies and do a lot of good, but the industry is little regulated, a three-month Associated Press investigation found earlier this year.
On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett Jr. and Donor Referral Services of Raleigh, N.C., citing “serious deficiencies” in manufacturing practices. In some cases, records did not match what official death certificates showed, and left out details like a donor’s history of cancer or drug use that may have made the donor’s tissue ineligible for transplant, the FDA’s order says.
Companies voluntarily recalling tissues supplied by the Raleigh firm are Alamo Tissue Services of San Antonio, Texas; Lost Mountain Tissue Bank of Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of US Tissue’s assets in March, is handling US Tissue’s recall).
However, tissues typically are distributed nationwide, so patients anywhere could be affected.
An industry group, the American Association of Tissue Banks, estimates that fewer than 100 donors are involved in the Raleigh company’s case. But each donor can provide 100 or more tissues, and the company also operated in Las Vegas from 2004 to 2005, the FDA notes.
“Although this is an extremely serious matter,” says an association statement, this case appears much smaller in scope than one earlier this year involving Biomedical Tissue Services, a now-defunct New Jersey company that may have provided up to 20,000 potentially risky tissue products.
Good treatment and processing methods can make tissue safe “even if it was not screened properly or came from an infected donor,” said Dr. Marion Kainer, a Tennessee Department of Health infectious disease expert who formerly investigated tissue cases for the CDC.
Most risky, she said, is so-called “fresh-frozen” tissue like cartilage, which cannot be sterilized without ruining the tissue.
“The chances of that being contaminated are much greater” than with bone, for instance, which can be treated with radiation to destroy germs, she said.
No one knows whether someone can develop cancer if they receive tissue from a cancer patient. That’s why such donors are supposed to be rejected.
Still, specialists believe the chances of someone getting a disease from these tissues is small.
“The fact is, we don’t know the risk, but it’s thought to be low,” McDonald said.
The current scandals involve “a very small subset” of the total tissue supply, said Areta Kupchyk, a former FDA attorney who helped write tissue regulations.
If patients cannot get satisfactory answers from their doctors on all the companies involved in supplying their tissue, “that’s when they should start making more demands,” she said.